Is Male Breast Cancer Overlooked in Clinical Trials?

Three and a half years ago, Oliver Bogler, PhD, a cancer biologist and Senior Vice President of Academic Affairs at the University of Texas MD Anderson Cancer Center, saw his personal and professional worlds collide. He received a cancer diagnosis—one that mirrored his wife’s.

“Some might say that Irene and I have taken sharing things in our marriage to a fault: the journey of breast cancer,” Dr. ­Bogler said in a presentation at the American Society of Breast Surgeons Annual Meeting, where he described his experience as a patient, survivor, and advocate.1 Male breast cancer represents about 1% of all newly diagnosed cases, he noted.

Both Dr. Bogler and his wife, Irene Newsham, were diagnosed at age 46 with invasive ductal carcinoma. Both tested positive for the estrogen receptor and progesterone receptor and negative for HER2/neu. His wife had stage II disease, whereas his tumor was stage III. They both underwent neoadjuvant chemotherapy, mastectomies (hers with reconstruction), then radiation therapy. Both are being treated with endocrine therapy: hers, anastrozole and his, tamoxifen.

What Are the Odds?

Dr. Bogler’s story was “typical” of breast cancer, he said in an interview with The ASCO Post. “I felt a lump in my right breast. I couldn’t imagine I would have the same disease as my wife,” he said, “saying over breakfast, ‘Honey, I think I have what you have. I mean, what are the odds?’”

While the odds do seem remote, several followers of his blog (www.malebreastcancerblog.org) shared similar stories, he said.

Dr. Bogler noted his primary care physician was appropriately concerned and ordered the lump evaluated, thus leading to prompt diagnosis and treatment.

His hot flashes have abated, but other side effects have lingered. Dr. Bogler said he is determined to do everything possible to stay healthy for his family, including completing 10 years of tamoxifen.

“I have had effective treatment, and I am 42 months out, without evidence of disease,” he said.

Though data regarding outcomes of male breast cancer patients are slim, most studies suggest that with current treatment regimens men fare as well as women.

Clinical Trials Short on Male Patients

At the American Society of Breast Surgeons Annual Meeting, Dr. Bogler highlighted the lack of breast cancer clinical trial options for men and encouraged investigators to design breast cancer trials to be more inclusive.

In 2013, he published an analysis showing that only one-third of breast cancer trials were open to male patients.2 More recently, he scoured the clinicaltrials.gov database, found 6,028 trials, and discovered that exclusions were still the norm.

“When you filter out to focus on those currently accruing, the proportion stays the same,” he said. “And by type of trial, the proportion of surgical trials for which males are eligible is only one-quarter.”

Breast Cancer in Men

Only one in three clinical trials involving breast cancer patients includes males, dropping to fewer than one in five in phase III.

This proportion has not changed in recent years.

“In general when male breast cancer is studied, it’s an epidemiological study,” he added.

About half the clinical trials involving biologics are open to men, suggesting that perhaps with the newer therapies there may be greater opportunities for male breast cancer patients, he added.

Furthermore, the proportion differs by phase. While about 60% of phase I trials are open to both men and women, only 18% of phase III trials involve men. Many trials are designed upon previous trial templates. “There’s inertia in the system,” he observed.

“The good news is that men have access to more experimental treatments (in phase I trials), but the lack of men in phase III trials is a concern,” he said.

Dr. Bogler was accepted into a study led by Elizabeth Mittendorf, MD, also of MD Anderson, of an adjuvant HER2-derived peptide vaccine. “That was worth a tremendous amount to me,” he said.

‘Include Us!’

Dr. Bogler urged other investigators to “include us [in trial design], if there’s not strong rationale not to.… I think excluding men from a clinical trial for which their disease is a match should perhaps require justification in the context of established guidelines for ethical subject selection,” he maintained.

Personally, he would like to know whether an aromatase inhibitor would be preferable to tamoxifen, for the treatment of his own cancer. There have been no comparisons in men.

The European Organization for Research and Treatment of Cancer (EORTC) has decided to bridge this data gap by conducting a study of approximately 1,200 male breast cancer patients. It is a prospective international registry of all male breast cancer patients treated at the participating institutions for 30 months. It will describe patterns of care and assess outcomes, including quality of life. This program has generated worldwide interest, Dr. Bogler said. ■